TY - JOUR
T1 - Comparative Effectiveness of Nivolumab and Ipilimumab Plus Chemotherapy Versus Pembrolizumab Plus Chemotherapy in PD-L1 Negative Metastatic Non-Small Cell Lung Cancer Patients
AU - Verschueren, Marjon V.
AU - Hiensch, Dagmar T.A.
AU - Plomp, Peter M.J.
AU - Kastelijn, Lisanne A.
AU - van de Garde, Ewoudt M.W.
AU - Peters, Bas J.M.
N1 - Publisher Copyright:
© 2025 The Authors
PY - 2025/1/25
Y1 - 2025/1/25
N2 - Background: Recently, the combination of nivolumab, ipilimumab and chemotherapy (NIC) became available for the treatment of metastatic non-small cell lung cancer (mNSCLC) patients, introducing a new treatment option. This study aimed to compare the treatment response and real-world outcomes of NIC with the current standard of care pembrolizumab plus chemotherapy (PC) in PD-L1 negative mNSCLC patients treated in clinical practice and to compare these outcomes with the results of the Checkmate-9LA trial. Methods: All mNSCLC patients with PD-L1<1% treated with NIC or PC at 2 large teaching hospitals in the Netherlands between 2019 and 2023 were included. The objective response rate (ORR) and progression-free survival (PFS) and treatment characteristics of patients treated with NIC were compared to those of patients treated with PC. Additionally, the real-world outcomes of NIC were compared to the results from the CheckMate 9LA trial. A multivariate Cox regression was used to calculate PFS hazard ratios (HR). Results: PD-L1 negative mNSCLC patients treated with NIC had a higher ORR than those treated with PC (41% versus 27%, P = .08). The PFS was slightly longer for patients treated with NIC versus PC (5.5 vs. 4.5 months, aHR = 0.91 [95% CI 0.59-1.58]), although not statistically significant. The treatment discontinuation rates were comparable between the real-world NIC and PC cohorts (72% vs. 68%), mostly due to disease progression (67% vs. 64%). The outcomes for patients treated with NIC in clinical practice were comparable to the Checkmate-9LA trial. Conclusion: For mNSCLC patients with <1% PD-L1 expression, the treatment responses to NIC were numerically better than to PC. Larger cohorts with longer follow-up periods and overall survival endpoints are needed to further establish the role of NIC in PD-L1 negative patients.
AB - Background: Recently, the combination of nivolumab, ipilimumab and chemotherapy (NIC) became available for the treatment of metastatic non-small cell lung cancer (mNSCLC) patients, introducing a new treatment option. This study aimed to compare the treatment response and real-world outcomes of NIC with the current standard of care pembrolizumab plus chemotherapy (PC) in PD-L1 negative mNSCLC patients treated in clinical practice and to compare these outcomes with the results of the Checkmate-9LA trial. Methods: All mNSCLC patients with PD-L1<1% treated with NIC or PC at 2 large teaching hospitals in the Netherlands between 2019 and 2023 were included. The objective response rate (ORR) and progression-free survival (PFS) and treatment characteristics of patients treated with NIC were compared to those of patients treated with PC. Additionally, the real-world outcomes of NIC were compared to the results from the CheckMate 9LA trial. A multivariate Cox regression was used to calculate PFS hazard ratios (HR). Results: PD-L1 negative mNSCLC patients treated with NIC had a higher ORR than those treated with PC (41% versus 27%, P = .08). The PFS was slightly longer for patients treated with NIC versus PC (5.5 vs. 4.5 months, aHR = 0.91 [95% CI 0.59-1.58]), although not statistically significant. The treatment discontinuation rates were comparable between the real-world NIC and PC cohorts (72% vs. 68%), mostly due to disease progression (67% vs. 64%). The outcomes for patients treated with NIC in clinical practice were comparable to the Checkmate-9LA trial. Conclusion: For mNSCLC patients with <1% PD-L1 expression, the treatment responses to NIC were numerically better than to PC. Larger cohorts with longer follow-up periods and overall survival endpoints are needed to further establish the role of NIC in PD-L1 negative patients.
KW - Anti-cancer treatments
KW - Early effectiveness
KW - Observational study
KW - Real-world evidence
KW - Real-world outcomes
UR - http://www.scopus.com/inward/record.url?scp=85217810245&partnerID=8YFLogxK
U2 - 10.1016/j.cllc.2025.01.009
DO - 10.1016/j.cllc.2025.01.009
M3 - Article
AN - SCOPUS:85217810245
SN - 1525-7304
JO - Clinical Lung Cancer
JF - Clinical Lung Cancer
ER -